The Brazilian vaccine against Covid-19 took an important step this Thursday (13), the date on which the first clinical study begins that will apply the immunizer in 90 volunteers aged between 18 and 55 years old. Phase 1 of the study will randomly choose the safest dose and dose regimen that stimulates a durable antibody response that neutralizes the body against the new coronavirus.
“We are now going to measure the specific immune response and assess the cellular immunity of the participants,” explained infectious disease specialist Roberto Badaró, responsible for research and development of the vaccine, in a ceremony held at the headquarters of the National Service for Industrial Learning (Senai), in Salvador. .
The researcher’s expectation is that the first phase of the study will be completed in three months, and that, if all goes well, in a year or so the vaccine will be available.
In phase 2, which will involve 400 volunteers, the vaccine’s efficiency will be tested; and phase 3 is that of large-scale administration.
First application of the Brazilian vaccine
The first to receive the dose of the Brazilian vaccine was the asset security technician Wenderson Nascimento Souza, 34 years old. The application of the immunizing agent was made by the Secretary of Research and Scientific Training of the Ministry of Science, Technology and Innovation (Sepef/MCTI), Marcelo Morales.
Present at the ceremony, the Minister of Science, Technology and Innovation, Marcos Pontes, said that January 13, 2022 is a “historic day” both for science in Brazil and for Brazilians.
“In this year of the bicentennial of the independence of Brazil, we start the independence of Brazil in the production of vaccines. We are at an inflection point in the history of Brazil”, he said, highlighting the rescue role that science played in several difficult moments for humanity.
Pontes recalled that there are three types of vaccines, imported, licensed and national, those made by Brazilian scientists. “It is important for the country to have sovereignty, self-sufficiency and independence in the production of items that are so important for the lives of Brazilians,” he said.
“From now on, we can say, in a reduced way, that if the planet cannot sell vaccines to Brazil, Brazil can sell vaccines to the planet“, he added.
The MCTI CIMATEC HDT RNA vaccine is made up of two parts, which are mixed together before application: a replicon RNA molecule (repRNA) and an emulsion composed of water and a special type of oil and magnetic molecules, called Lion, which helps to protect the repRNA molecule and transport it to target cells.
Once inside cells, repRNA is recognized as messenger RNA by ribosomes, which are structures that produce proteins, with the instructions carried by the RNA. Ribosomes first make the replicon, which makes multiple copies of itself, and then the coronavirus proteins, which are broken into small pieces and exposed to our immune system. The body then identifies the fragments as something foreign and starts producing antibodies against the new coronavirus.
According to infectious disease specialist Roberto Badaró, the Brazilian vaccine, which is of the third generation, has some specific benefits, such as the use of a smaller number of components, and can be applied in lower doses and without the need for consecutive immunizations. “We may, in a sequence and with the ability to synthesize the five variants in a single protein, have a vaccine with the five variants in the future. Therefore, we can have the vaccine that will be routinely used”, explained the infectious disease doctor.
The pre-clinical and clinical development of the vaccine has the participation of the United States, Brazil and India, through a partnership between the HDT BioCorp companies. (United States), Senai Cimatec (Brazil) and Gennova Biopharmaceuticals (India). In Brazil, the partnership is supported by RedeVírus and financed by the MCTI.